Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, 46819-46820 [2011-19601]
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46819
Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average
burden
per recordkeeping
Total hours
558.6(c)(1) through (c)(4) ....................................................
558.6(e)(1) through (e)(4) ....................................................
112,500
5,000
10
75
1,125,000
375,000
.0167
.0167
18,788
6,263
Total ..............................................................................
........................
........................
........................
........................
25,051
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the times required for
record preparation and maintenance is
based on Agency communication with
industry and Agency records and
experience.
Dated: July 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–19603 Filed 8–2–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0016. The
approval expires on June 13, 2014. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Food and Drug Administration
Dated: July 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[Docket No. FDA–2010–N–0258]
[FR Doc. 2011–19602 Filed 8–2–11; 8:45 am]
BILLING CODE 4160–01–P
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Submission of Petitions: Food
Additive, Color Additive (Including
Labeling), and Generally Recognized
as Safe Affirmation; Electronic
Submission Using Food and Drug
Administration Form 3503
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Submission of Petitions: Food
Additive, Color Additive (Including
Labeling), and Generally Recognized as
Safe Affirmation; Electronic Submission
Using Food and Drug Administration
Form 3503’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 30, 2010 (75
FR 52954), the Agency announced that
the proposed information collection had
been submitted to OMB for review and
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:48 Aug 02, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA–2011–N–0535]
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information associated
with the submission of notifications of
health claims or nutrient content claims
SUMMARY:
PO 00000
Frm 00099
Fmt 4703
Sfmt 4703
Submit either electronic or
written comments on the collection of
information by October 3, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
DATES:
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
SUPPLEMENTARY INFORMATION:
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry: Notification of a Health Claim
or Nutrient Content Claim Based on an
Authoritative Statement of a Scientific
Body
AGENCY:
based on authoritative statements of
scientific bodies of the U.S.
Government.
E:\FR\FM\03AUN1.SGM
03AUN1
46820
Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Notices
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance for Industry: Notification of a
Health Claim or Nutrient Content Claim
Based on an Authoritative Statement of
a Scientific Body—(OMB Control
Number 0910–0374)—Extension
Section 403(r)(2)(G) and (r)(3)(C) of
the Federal Food, Drug and Cosmetic
Act (the FD&C Act) (21 U.S.C.
343(r)(2)(G) and (r)(3)(C)), as amended
by the FDA Modernization Act of 1997,
provides that any person may market a
food product whose label bears a
nutrient content claim or a health claim
that is based on an authoritative
statement of a scientific body of the U.S.
Government or the National Academy of
Sciences (NAS). Under this section of
the FD&C Act, a person that intends to
use such a claim must submit a
notification of its intention to use the
claim 120 days before it begins
marketing the product bearing the
claim. In the Federal Register of June
11, 1998 (63 FR 32102), FDA announced
the availability of a guidance entitled
‘‘Guidance for Industry: Notification of
a Health Claim or Nutrient Content
Claim Based on an Authoritative
Statement of a Scientific Body.’’ The
guidance provides the Agency’s
interpretation of terms central to the
submission of a notification and the
Agency’s views on the information that
should be included in the notification.
The Agency believes that the guidance
will enable persons to meet the criteria
for notifications that are established in
section 403(r)(2)(G) and (r)(3)(C) of the
FD&C Act. In addition to the
information specifically required by the
FD&C Act to be in such notifications,
the guidance states that the notifications
should also contain information on
analytical methodology for the nutrient
that is the subject of a claim based on
an authoritative statement. FDA intends
to review the notifications the Agency
receives to ensure that they comply with
the criteria established by the FD&C Act.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Section of the FD&C Act
Average
burden per
response
Total annual
responses
Total hours
403(r)(2)(G) (nutrient content claims) ..................................
403(r)(2)(C) (health claims) .................................................
Guidance for Notifications ....................................................
1
1
2
1
1
1
1
1
2
250
450
1
250
450
2
Total ..............................................................................
........................
........................
........................
........................
702
srobinson on DSK4SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on FDA’s
experience with health claims, nutrient
content claims, and other similar
notification procedures that fall under
our jurisdiction. To avoid estimating the
number of respondents as zero, the
Agency estimates that there will be one
or fewer respondents annually for
nutrient content claim and health claim
notifications. FDA estimates that it will
receive one nutrient content claim
notification and one health claim
notification per year over the next 3
years.
Section 403(r)(2)(G) and (r)(3)(C) of
the FD&C Act requires that the
notification include the exact words of
the claim, a copy of the authoritative
statement, a concise description of the
basis upon which such person relied for
determining that this is an authoritative
statement as outlined in the FD&C Act,
and a balanced representation of the
scientific literature relating to the
relationship between a nutrient and a
disease or health-related condition to
which a health claim refers or to the
nutrient level to which the nutrient
content claim refers. This balanced
representation of the scientific literature
is expected to include a bibliography of
the scientific literature on the topic of
VerDate Mar<15>2010
16:24 Aug 02, 2011
Jkt 223001
the claim and a brief, balanced account
or analysis of how this literature either
supports or fails to support the
authoritative statement.
Since the claims are based on
authoritative statements of a scientific
body of the U.S. Government or NAS,
FDA believes that the information that
is required by the FD&C Act to be
submitted with a notification will be
readily available to a respondent.
However, the respondent will have to
collect and assemble that information.
Based on communications with firms
that have submitted notifications, FDA
estimates that 1 respondent will take
250 hours to collect and assemble the
information required by the statute for
a nutrient content claim notification.
Further, FDA estimates that 1
respondent will take 450 hours to
collect and assemble the information
required by the statute for a health claim
notification.
Under the guidance, notifications
should also contain information on
analytical methodology for the nutrient
that is the subject of a claim based on
an authoritative statement. The
guidance applies to both nutrient
content claim and health claim
notifications. FDA has determined that
PO 00000
Frm 00100
Fmt 4703
Sfmt 4703
this information should be readily
available to a respondent and, thus, the
Agency estimates that it will take a
respondent 1 hour to incorporate the
information into each notification. The
Agency expects there will be 2
respondents for a total of 2 hours.
Dated: July 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–19601 Filed 8–2–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0513]
Proposal To Refuse To Approve a
Supplemental New Drug Application
for Bromday (Bromfenac Ophthalmic
Solution), 0.09%; Opportunity for a
Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA), the Director of
SUMMARY:
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Notices]
[Pages 46819-46820]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19601]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA-2011-N-0535]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry: Notification of a Health Claim
or Nutrient Content Claim Based on an Authoritative Statement of a
Scientific Body
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
associated with the submission of notifications of health claims or
nutrient content claims based on authoritative statements of scientific
bodies of the U.S. Government.
DATES: Submit either electronic or written comments on the collection
of information by October 3, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether
[[Page 46820]]
the information will have practical utility; (2) the accuracy of FDA's
estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology.
Guidance for Industry: Notification of a Health Claim or Nutrient
Content Claim Based on an Authoritative Statement of a Scientific
Body--(OMB Control Number 0910-0374)--Extension
Section 403(r)(2)(G) and (r)(3)(C) of the Federal Food, Drug and
Cosmetic Act (the FD&C Act) (21 U.S.C. 343(r)(2)(G) and (r)(3)(C)), as
amended by the FDA Modernization Act of 1997, provides that any person
may market a food product whose label bears a nutrient content claim or
a health claim that is based on an authoritative statement of a
scientific body of the U.S. Government or the National Academy of
Sciences (NAS). Under this section of the FD&C Act, a person that
intends to use such a claim must submit a notification of its intention
to use the claim 120 days before it begins marketing the product
bearing the claim. In the Federal Register of June 11, 1998 (63 FR
32102), FDA announced the availability of a guidance entitled
``Guidance for Industry: Notification of a Health Claim or Nutrient
Content Claim Based on an Authoritative Statement of a Scientific
Body.'' The guidance provides the Agency's interpretation of terms
central to the submission of a notification and the Agency's views on
the information that should be included in the notification. The Agency
believes that the guidance will enable persons to meet the criteria for
notifications that are established in section 403(r)(2)(G) and
(r)(3)(C) of the FD&C Act. In addition to the information specifically
required by the FD&C Act to be in such notifications, the guidance
states that the notifications should also contain information on
analytical methodology for the nutrient that is the subject of a claim
based on an authoritative statement. FDA intends to review the
notifications the Agency receives to ensure that they comply with the
criteria established by the FD&C Act.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Section of the FD&C Act Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
403(r)(2)(G) (nutrient content 1 1 1 250 250
claims)........................
403(r)(2)(C) (health claims).... 1 1 1 450 450
Guidance for Notifications...... 2 1 2 1 2
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 702
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
These estimates are based on FDA's experience with health claims,
nutrient content claims, and other similar notification procedures that
fall under our jurisdiction. To avoid estimating the number of
respondents as zero, the Agency estimates that there will be one or
fewer respondents annually for nutrient content claim and health claim
notifications. FDA estimates that it will receive one nutrient content
claim notification and one health claim notification per year over the
next 3 years.
Section 403(r)(2)(G) and (r)(3)(C) of the FD&C Act requires that
the notification include the exact words of the claim, a copy of the
authoritative statement, a concise description of the basis upon which
such person relied for determining that this is an authoritative
statement as outlined in the FD&C Act, and a balanced representation of
the scientific literature relating to the relationship between a
nutrient and a disease or health-related condition to which a health
claim refers or to the nutrient level to which the nutrient content
claim refers. This balanced representation of the scientific literature
is expected to include a bibliography of the scientific literature on
the topic of the claim and a brief, balanced account or analysis of how
this literature either supports or fails to support the authoritative
statement.
Since the claims are based on authoritative statements of a
scientific body of the U.S. Government or NAS, FDA believes that the
information that is required by the FD&C Act to be submitted with a
notification will be readily available to a respondent. However, the
respondent will have to collect and assemble that information. Based on
communications with firms that have submitted notifications, FDA
estimates that 1 respondent will take 250 hours to collect and assemble
the information required by the statute for a nutrient content claim
notification. Further, FDA estimates that 1 respondent will take 450
hours to collect and assemble the information required by the statute
for a health claim notification.
Under the guidance, notifications should also contain information
on analytical methodology for the nutrient that is the subject of a
claim based on an authoritative statement. The guidance applies to both
nutrient content claim and health claim notifications. FDA has
determined that this information should be readily available to a
respondent and, thus, the Agency estimates that it will take a
respondent 1 hour to incorporate the information into each
notification. The Agency expects there will be 2 respondents for a
total of 2 hours.
Dated: July 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19601 Filed 8-2-11; 8:45 am]
BILLING CODE 4160-01-P
